Jan 26, 2023
Biotech innovator combats the largest unresolved problem in wound care
Chronic wounds are a persistent and pricey problem for patients and health care systems around the world.
Defined as “wounds that fail to proceed through the normal phases of wound healing in an orderly and timely manner,” chronic wounds range from severe burns to bedsores to diabetic ulcers.
Whatever the cause, they all carry costs in medical care as well as pain and decreased quality of life, and many can be attributed to something you may have never heard of: biofilms.
“Biofilms are formed when bacteria and/or fungi adhere to surfaces and excrete a glue-like substance that acts as an anchor and provides protection from the environment,” making “bacteria up to 1,000 times more resistant to antibiotics, antimicrobial agents, disinfectants and the host immune system,” according to Kane Biotech Inc. (TSX-V:KNE | OTCQB:KNBIF).
The Canadian company’s latest product, coactiv+™ Antimicrobial Hydrogel, is designed to address biofilms and the problems they cause in chronic wounds — and at a price that will allow it to be covered by Medicare in the U.S. as well as insurers around the globe, a crucial distinction for a premium product.
“The things we normally used very effectively to kill bacteria — like antibiotics, our own immune cells, our antibodies — they frequently are ineffective in killing these biofilm bacteria,” explains Dr. Gregory Schultz, a University of Florida professor emeritus and Kane Biotech’s chief scientific officer.
Schultz says Kane’s coactiv+™ technology not only addresses biofilm-impaired healing, but it also contains an antimicrobial molecule that allows it to be effective in healing chronic wounds. And he notes the gel could be applied by a doctor, nurse or even patients themselves.
Biofilms are a serious problem in the majority of chronic wounds
“It’s a great technology. It’s important technology,” says Marc Edwards, Kane Biotech’s CEO, noting biofilms are one of the largest unresolved problems associated with chronic wounds.
Studies have shown a prevalence of biofilms in more than 78 per cent of chronic wounds and the U.S. Centers for Disease Control and Prevention have identified resistant bacteria, to which biofilms are a major contributor, as a serious burden to health care systems.
Edwards says that Kane has filed a 510(k) application with the U.S. Food and Drug Administration —a submission that demonstrates that the medical device (in this case, Kane’s coactiv+™ Antimicrobial Hydrogel) “is as safe and effective, that is, substantially equivalent, to a legally marketed device” — so it can bring the product to market. The review process is well underway, and approval is expected by the second quarters of 2023, with a commercial launch planned for the third quarter.
Edwards is optimistic about the product’s prospects because of the cost of chronic wounds to health care systems. For instance, “Studies of [U.S.] Medicare data estimate the cost to treat these wounds at between US$28 billion and US$96 billion.” And according to a 2022 report by Grand View Research Inc., the global wound care market is estimated to grow to US$29.6 billion by 2030.
In addition, Hydrogels are used daily by wound care practitioners, Edwards says, representing a $150-$200 million market in the U.S. that is ripe for a clearly differentiated, premium product such as coactiv+™.
The Kane product is distinct both in its ability to inhibit biofilm formation as well as in its thermo-reversible formulation, which means it gels at warmer temperatures and liquifies at cooler temperatures; thus, it can be cooled to be poured on to burn wound — it will gel when in contact with body heat — and rinsed off easily with cold water.
Kane Biotech will soon be in the South American market thanks to partnership
Already, Kane Biotech has taken steps to access the market for wound care and hydrogels by signing a distribution agreement earlier this year with Salud Pharma S.A., which will, once the product has received FDA approval, commercialize coactiv+™ (as well as Kane’s DermaKB™ scalp care products) throughout Colombia, Panama and Costa Rica.
In addition to wound and surgical care, Kane Biotech — which has been granted approximately US$3.1 million in research funding from the U.S. Department of Defense for DispersinB®, the company’s other patented antibiofilm technology — is also focused on dermatology and animal health.
The company has also developed DermaKB™ scalp detoxifiers and shampoos designed to break down biofilm. Containing its proprietary coactiv+™ technology, these lineups of products are proven to help with scalp conditions such as dandruff and seborrheic dermatitis.
Edwards notes Kane’s anti-biofilm technology serves as a platform on which to build a variety of products.
“Besides our focus in R&D, we are also a product development firm. We’re looking to build multiple royalty streams,” Edwards says.
“We’re really at an inflection point. With the launch of our coactiv+™ Antimicrobial Wound Gel and developing product pipeline, we aim to tap into a multi-million-dollar market that is ripe for the picking. Since this market is still relatively untouched, we believe that there is a real opportunity to own it.”
Learn more about Kane Biotech Inc. on its website as well as: